Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults

NCT ID: NCT01353820

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-03-31

Brief Summary

The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.

Conditions

Hypercholesterolemia

Keywords

Midly hypercholesterolemic subjects; Probiotic; Cholesterol lowering; Dairy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1 = Tested product

Group Type: ACTIVE_COMPARATOR

1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL

Intervention Type: DIETARY_SUPPLEMENT

1- Intervention with test product ( \>10E8 to \<5.10E9 cfu/ml of L. delbruckii lactis )

2 = Control product

Group Type: SHAM_COMPARATOR

2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus

Intervention Type: DIETARY_SUPPLEMENT

2- Intervention with control product

Interventions

1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL

1- Intervention with test product ( \>10E8 to \<5.10E9 cfu/ml of L. delbruckii lactis )

Intervention Type: DIETARY_SUPPLEMENT

2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus

2- Intervention with control product

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• male and female aged 18-75 years;
• BMI between 19 and 30 kg/m2,
• LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,
• stabilized hypercholesterolemia (since more than 3 months),
• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
• used to consume dairy products,
• for female: effective contraceptive methods used,
• agreeing to a written informed consent

Exclusion Criteria

• plasma triglycerides (TG) levels > 350 mg/dL (4 mmol//L),
• any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,
• known allergy or hypersensitivity to milk proteins,
• systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
• subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,
• subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
• diabetic subjects (type I and type II),
• any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
• for female subject: pregnancy, breast feeding or intention to become pregnant during the study,
• for female subject: subject likely to change her contraceptive method during the study,
• active heavy cigarette smokers (reported more than 20 cigarettes / day),
• subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AMED s.r.o (Poliklinika Budějovická)

Prague, , Czechia

Countries

Czechia

Other Identifiers

NU280

Identifier Type: -

Identifier Source: org_study_id